Table 2.
Baseline patient and tumor characteristics
| Trastuzumab (n = 33) | Lapatinib (n = 34) | Trastuzumab + Lapatinib (n = 33) | Total (N = 100) | |
|---|---|---|---|---|
|
Demographics | ||||
|
Age (years) |
|
|
|
|
| Mean (standard deviation) |
51.1 (10.90) |
50.8 (8.76) |
49.2 (10.47) |
50.4 (10.01) |
| Median (range) |
54.0 (21-67) |
52.0 (25-67) |
50.0 (28-66) |
51.5 (21-67) |
| <65 years, n (%) |
31 (94) |
32 (94) |
30 (91) |
93 (93) |
| ≥65 years, n (%) |
2 (6) |
2 (6) |
3 (9) |
7 (7) |
|
Menopausal status, n (%) |
|
|
|
|
| Postmenopausal |
19 (58) |
19 (56) |
16 (48) |
54 (54) |
| Sterile |
5 (15) |
5 (15) |
6 (18) |
16 (16) |
| Potential to bear children |
9 (27) |
10 (29) |
11 (33) |
30 (30) |
|
Race, n (%) |
|
|
|
|
| African American |
8 (24) |
1 (3) |
2 (6) |
11 (11) |
| White/Caucasian |
25 (76) |
27 (79) |
29 (88) |
81 (81) |
| Other |
0 |
6 (18) |
2 (6) |
8 (8) |
|
Disease characteristics |
|
|
|
|
|
Histology, n (%) |
|
|
|
|
| Adenocarcinoma |
3 (9) |
6 (18) |
1 (3) |
10 (10) |
| Medullary |
0 |
0 |
1 (3) |
1 (1) |
| Lobular invasive |
0 |
1 (3) |
2 (6) |
3 (3) |
| Infiltrating ductal NOS |
26 (79) |
23 (68) |
22 (67) |
71 (71) |
| Other |
4 (12) |
4 (12) |
7 (21) |
15 (15) |
|
Grade, n (%) |
|
|
|
|
| Not assessed |
3 (9) |
3 (9) |
3 (9) |
9 (9) |
| Well differentiated |
0 |
3 (9) |
1 (3) |
4 (4) |
| Moderately |
10 (30) |
7 (21) |
12 (36) |
29 (29) |
| Poorly |
20 (61) |
21 (62) |
17 (52) |
58 (58) |
|
Hormone receptor status, n (%) |
|
|
|
|
| Positive (ER + and/or PR+) |
15 (45) |
14 (41) |
20 (61) |
49 (49) |
| Negative (ER- and PR-) |
18 (55) |
20 (59) |
13 (39) |
51 (51) |
|
HER2-IHC status, n (%) |
|
|
|
|
| 0 |
2 (6) |
0 |
1 (3) |
3 (3) |
| 1+ |
0 |
0 |
1 (3) |
1 (1) |
| 2+ |
4 (12) |
3 (9) |
0 |
7 (7) |
| 3+ |
22 (67) |
26 (76) |
26 (79) |
74 (74) |
| Unknown |
5 (15) |
5 (15) |
5 (15) |
5 (15) |
|
HER2-FISH status, n (%) |
|
|
|
|
| Positive |
27 (82) |
24 (71) |
23 (70) |
74 (74) |
| Negative |
0 |
1 (3) |
0 |
1 (1) |
| Unknown |
6 (18) |
9 (26) |
10 (30) |
25 (25) |
|
Tumor size, n (%) |
|
|
|
|
| T2 |
22 (67) |
12 (35) |
22 (67) |
56 (56) |
| T3 |
8 (24) |
11 (32) |
6 (18) |
25 (25) |
| T4 |
3 (9) |
8 (24) |
5 (15) |
16 (16) |
| Tx |
0 |
3 (9) |
0 |
3 (3) |
|
TNM stage: regional nodes, n (%) |
|
|
|
|
| N0 |
18 (55) |
11 (32) |
13 (39) |
42 (42) |
| N1 |
12 (36) |
16 (47) |
14 (42) |
42 (42) |
| N2 | 3 (9) | 7 (21) | 6 (18) | 16 (16) |
Abbreviations:ER estrogen receptor, FISH fluorescence in situ hybridization, HER2 human epidermal growth factor receptor 2, IHC immunohistochemistry, NOS not otherwise specified, PR progesterone receptor, TNM tumor, node, metastasis.